Clovis (CLVS) Focuses On Label Expansion, Rubraca Impresses

We issued an updated research report on Boulder, CO-based Clovis Oncology, Inc. (NASDAQ:CLVS) on Aug 14.

Rubraca has shown impressive growth trend in 2017 on the back of the company’s commercialization efforts. Rubraca sales doubled sequentially in the second quarter. Rubraca sales were $14.6 million in the quarter. However, general and administrative expenses increased 276% year over year to $29.2 million due to commercialization efforts.

Rubraca is the only approved drug in the company’s portfolio and is the first and only oral PARP inhibitor to receive approval as monotherapy. The drug is approved for patients who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Clovis is conducting two confirmatory studies - ARIEL3 and ARIEL4 – for converting the accelerated approval to continued approval of Rubraca. Rubraca was in-licensed from Pfizer Inc. (NYSE:PFE) in 2011.

In Jun 2017, the company announced promising progression-free survival (PFS) and safety results from the pivotal maintenance confirmatory study, ARIEL3. The study demonstrated that, Rubraca has a meaningful impact in delaying disease recurrence in advanced ovarian cancer patients. Clovis intends to submit a supplemental new drug application (sNDA) for label expansion of Rubraca in the second-line or later maintenance indication for advanced ovarian cancer by October this year. The company believes that the label will increase patient population by at least four times.

Meanwhile, the second phase III confirmatory study - ARIEL4 - is evaluating Rubraca versus chemotherapy in patients who have failed two prior lines of therapy.

Meanwhile, Rubraca is also under review in the EU for a comparable ovarian cancer indication. An approval is expected in EU in the first quarter of 2018 and Clovis is establishing the commercial infrastructure for the same.

Rubraca has immense commercial potential in the target market as there is tremendous demand for PARP inhibitors. Per the American Cancer Society, ovarian cancer ranks fifth in deaths from cancer among women. Over 22,440 cases of ovarian cancer are estimated to be diagnosed in the U.S. in 2017. There is a huge unmet need for new treatment options, given that one in four women with ovarian cancer has a germline or somatic BRCA mutation.

Clovis is also developing Rubraca in additional cancer indications either as monotherapy or in combination with other agents, including Tecentriq-Rubraca combination in gynecologic cancers. This combination study is sponsored by Roche. Moreover, the company collaborated with Bristol-Myers Squibb Company (NYSE:BMY) in Jul 2017 to evaluate the Rubraca in combination with the latter’s Opdivo in ovarian, breast and prostate cancer.

The ovarian cancer market is already crowded with the presence of major players. With the launch of Tesaro, Inc.’s (NASDAQ:TSRO) Zejula in Apr 2017, competition has intensified further.

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